BEUDAMED
    FDA Enforcement Class II Terminated

    Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.

    Recall: Z-0933-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0933-2022
    Event ID
    89801
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2022
    Initiation Date
    March 8, 2022
    Classification Date
    April 14, 2022
    Termination Date
    February 27, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.

    Reason

    The product was stored incorrectly due to improper storage controls which may lead to delayed results.

    Code Info

    Lot numbers 172093, exp. 06/30/2023; 174703, exp. 08/31/2023; and 169141, exp. 04/30/2023.

    Distribution

    Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.

    Quantity

    10 boxes